(Reuters) — Johnson & Johnson’s Janssen unit has sued Amgen Inc. over its plan to market a drug for ulcerative colitis and other conditions similar to J&J’s best-selling Stelara, saying it would infringe on two patents.
The trial was made public on Wednesday.
Stelara accounted for $9.1 billion of J&J’s $52 billion in global drug sales last year. Sales for the first nine months of this year were $7.3 billion, an increase of 7.9% compared to the same period last year.
The drug is also approved to treat Crohn’s disease, the skin condition psoriasis and a related form of arthritis. It is a biological drug, meaning it is made inside living cells.
A 2009 law allows companies to make so-called biosimilar versions of biological drugs that can replace them, much like generic versions of conventional drugs. However, J&J claims that Amgen failed to follow the legal process required under that law for the companies to litigate patent disputes.
If Amgen launches its drug, J&J said it would infringe on J&J̵7;s patents on the drug’s active ingredient and on its use to treat ulcerative colitis.
J&J told the court that an Amgen filing indicates that the US Food and Drug Administration could approve its biosimilar in the second or third quarter of 2023 and that Amgen intends to start selling it as early as next May.
An Amgen spokesperson said the company had no comment on the lawsuit. J&J said in a statement that Janssen is “confident in its intellectual property and has filed a lawsuit to protect its rights.”